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NCT Number: NCT01686607

Short and Long-term Safety of Micafungin and Other Parenteral Antifungal Agents

This multicenter observational cohort study proposes to establish the risks of short and long-term outcomes in users of parenteral micafungin and in users of other parenteral antifungal agents from 2005 through 2012 with follow-up until 2017.

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Key information

Conditions

Systemic Fungal Infections Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Sex eligibility

All sexes

Study type

Observational

Primary location

Site US4, Baltimore, Maryland, United States

Loading trial locations.

About this study

All eligible patients treated with a parenteral antifungal agent at any time during the years 2005-2012 in each of the participating hospitals, will be included in the study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • hospitalized and treated with parenteral antifungal medication
  • first time treatment of the patient with parenteral antifungal in the medical center was anytime from 2005 through 2012

Exclusion criteria

  • prior diagnosis of hepatocellular carcinoma
  • had received parenteral antifungal therapy during the 6 months prior to index hospitalization

Treatment and study plan

Parenteral micafungin application

Drug

Parenteral

Other parenteral antifungal drugs

Drug

Parenteral

Other names: caspofungin, anidulafungin, fluconazole, itraconazole, voriconazole, amphotericin B (various formulations), 'other antifungals' include the following drugs:

Primary outcomes

  1. Treatment-emergent hepatic injury or dysfunction

    Time frame: Up to 30 days after termination of the index treatment

    Data will be used of patients treated during the years 2005-2012 with a parenteral antifungal agent in the participating centers.

  2. Treatment-emergent renal failure or dysfunction

    Time frame: Up to 30 days after termination of the index treatment

    Data will be used of patients treated during the years 2005-2012 with a parenteral antifungal agent in the participating centers.

  3. Rehospitalization for the parenteral treatment of fungal infections

    Time frame: Up to 30 days after termination of the index treatment

    Data will be used of patients treated during the years 2005-2012 with a parenteral antifungal agent in the participating centers.

  4. Death from hepatocellular carcinoma (HCC)

    Time frame: Up to 13 years after treatment

    On a long-term basis up to 13 years from 2005-2017.

Sponsors and collaborators

Lead sponsor

Astellas Pharma Europe B.V.

Industry

Collaborators

  • World Health Information Science Consultants, LLC

Registry information

Official study title

A Multicenter Cohort Study of the Short and Long-term Safety of Micafungin and Other Parenteral Antifungal Agents

Acronym: MYCOS

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Sep 18, 2012
Registry last updated
Oct 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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